Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy

Medical Park Gaziantep Hospital1,500 enrolled

Overview

The aim of this study is to compare early postoperative outcomes of unselected consecutive patients underwent laparoscopic cholecystectomy (LC) under spinal versus general anesthesia.

Laparoscopic cholecystectomy (LC) is the gold standard surgical treatment of symptomatic cholecystectomy which traditionally performed under general anesthesia. Laparoscopy has provided many advantages over open surgery for the patients; however, general anesthesia adversely affects patients' early postoperative quality of life (POQoL). Spinal anesthesia which is a less invasive technique compared to general anesthesia has many advantages regarding the POQoL such as no need to wait for recovery from anesthesia, less nausea and vomiting, less or no pain at the end of surgery, no discomfort associated with intubation, early ambulation, fully awaken and oriented patient in the bed, and less anxious relatives. LC has been shown to be feasible under spinal anesthesia if performed with proper technique. There are many reports demonstrated the effectiveness and safety of LC under spinal anesthesia in selected patients. However, patients with complicated gallstone disease such as acute, gangrenous or subacute cholecystitis have been considered as unfit cases for LC under spinal anesthesia because of technical difficulties. On the other hand, spinal anesthesia has also been regarded as inappropriate for patients complying with American society for anesthesiology (ASA) III and IV due to the uncontrolled anesthesia risks. The aim of this study is to compare early postoperative outcomes of unselected consecutive patients underwent LC under spinal versus general anesthesia. If proportion of general anesthesia (PGA) / proportion of spinal anesthesia (PSA) denotes the proportion rate of outcomes in the general anesthesia group (GaG) / spinal anesthesia group (SaG), then two-sided test problem is assessed as follow: 1. Null hypothesis: H0: PGA = PSA. There is no difference between the two anesthesia techniques in terms of primary outcomes. 2. Null hypothesis: H1: PGA ≠ PSA There is a difference between the two anesthesia techniques in terms of primary outcomes.

Study Type

OBSERVATIONAL

Enrollment

1,500

Conditions

Cholecystitis Gallbladder Diseases

Interventions

Spinal anesthesiaPROCEDURE

Spinal anesthesia was used in patients who underwent LC

General anesthesiaPROCEDURE

General anesthesia was used in patients who underwent LC

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * All patients who underwent laparoscopic cholecystectomy for symptomatic gallstone disease with no restriction for age, gender, ethnicity, disease severity, and ASA grade. Exclusion Criteria: * Patients were excluded if they underwent concurrent surgeries, had malignancy suspicion, received or converted to open surgery, and patients who were under spinal anesthesia converted to general anesthesia.

Outcomes

Primary Outcomes

Change in pain level for the first day

Numerical rating scale (NRS) was used

Time frame: from baseline to postoperative 1, 2, 4 and 6 hours

Change in pain level for the first month

Numerical rating scale was used

Time frame: From postoperative 1 week to 1 month

Secondary Outcomes

Complications

All types of complications were assessed

Time frame: within the postoperative 1 month

Mortality

all causes of mortality were recorded

Time frame: within the postoperative 1 month

Gastrointestinal quality of life index

A standard form was used under the supervision of experienced independent personal

Time frame: change from baseline to postoperative 1 week and 1 month

Patient satisfaction

a verbal or visual scale was used

Time frame: at postoperative 1 month

Data from ClinicalTrials.gov

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